Vaporized Medicants and Methods of Use

ABSTRACT

A method and formulation for delivering a PDE-5 inhibitor in a vaporized state using low temperatures to vaporize the formulation. The formulation contains an inert non-reactive compound that lowers the heat of vaporization of the formulation, and the PDE-5 inhibitor. The formulation may optionally contain glycerin, alcohol, and/or water. Examples of inert non-reactive compounds that can sufficiently lower the heat of vaporization of the formulation include propylene glycol, vegetable glycerin and polysorbate. The formulation can be vaporized using a hand-held low temperature vaporizer or atomizer.

CROSS-REFERENCE TO RELATED APPLICATION

This patent application is a continuation-in-part of U.S. patentapplication Ser. No. 15/880,872, filed on Jan. 26, 2018, which is acontinuation-in-part of U.S. patent application Ser. No. 15/716,289,filed on Sep. 26, 2017, which is a continuation of U.S. patentapplication Ser. No. 15/008,154, filed on Jan. 27, 2016, which is acontinuation-in-part of U.S. patent application Ser. No. 14/937,737,filed on Nov. 10, 2015 (now U.S. Pat. No. 9,770,408), which is acontinuation-in-part of U.S. patent application Ser. No. 14/629,279,filed on Feb. 23, 2015 (now U.S. Pat. No. 9,283,180), which is acontinuation-in-part of U.S. patent application Ser. 13/653,320, filedon Oct. 16, 2012 (now U.S. Pat. No. 8,962,040), which is acontinuation-in-part of U.S. patent application Ser. No. 12/858,382,filed Aug. 17, 2010 (now U.S. Pat. No. 8,287,922), which claims thebenefit of U.S. Provisional Patent Application No. 61/234,562, filedAug. 17, 2009; U.S. patent application Ser. No. 14/937,737 is also acontinuation-in-part application of U.S. patent application Ser. No.13/846,617, filed Mar. 18, 2013, which is a continuation-in-part of U.S.patent application Ser. No. 12/858,373 filed on Aug. 17, 2010 (nowabandoned), which claims the benefit of U.S. Provisional PatentApplication No. 61/234,560, filed Aug. 17, 2009, which applications areincorporated in their entirety here by this reference.

TECHNICAL FIELD

This invention relates to methods and formulations for vaporizingmedicants and uses thereof.

BACKGROUND

When faced with a condition giving rise to bodily discomfort, such as adiseased state, disorder, ailment, normal bodily disruptions, and thelike, most people turn to medication, such as drugs, supplements, herbs,and the like for immediate relief from the symptoms that arise from theunderlying condition. There are certain legal and widely availableover-the-counter (OTC) medications and supplements that have beneficialeffects when used for a variety of common conditions. There are alsocertain controlled narcotics and pharmaceuticals prescribed by doctorsfor a variety of more serious conditions.

One of the most common routes of administration of these OTC andprescription drugs is oral administration. However, as with any oraldelivery of medication, it must pass through the digestive tract. Thereare a number of disadvantages of oral administration. For example,because the drug has to pass through the digestive system, the onset ofactivation of the drug is slow. In addition, in the digestive tract thedrug may be inactivated or destroyed, and therefore, lose its potency orefficacy. The drug itself can also cause problems in the digestivetract, or side effects, such as loss of appetite, diarrhea, acidity, andthe like. Furthermore, patients may be reluctant or unable to swallow apill.

Other routes of delivery exist, such as intradermal injections, patchapplications, inhalations, and the like. Each of these has its ownadvantages and disadvantages. Therefore, there is still room forimproving routes of administration of drugs.

For example, there are varieties of medicants which are safer, moreeffective, and more efficient with respect to efficacy if theiringestion is via inhalation of a vapor containing the medicant or itsactive ingredient rather than by gastrointestinal, intravenous orintramuscular delivery. However, most vaporization methodologies forinhalation are done at relatively high temperatures and, as a result,present risks or hurdles to either the efficacy of the medicant or thewell-being of the user.

Certain medicants are intended to affect the brain or the brain'sactions or activities but, given the accepted method ofingestion—gastrointestinal, intravenous, or intramuscular—thesemedicants can also have a variety of discomforting side effects due tothe nature of ingestion or injection. These include, but are not limitedto: gastro-intestinal complications, digestive disorders, high bloodpressure, and/or headaches.

Additionally, certain methods to vaporize and deliver these medicantshave drawbacks as well, specifically those that vaporize the medicantitself, changing the molecular or chemical structure of the medicant orthose that vaporize an excipient at a high temperature, once againchanging the molecular or chemical structure of the excipient andraising the risk of changing the chemical structure of the medicant whenit interacts with the vaporized excipient.

In order to ensure that the medicant is delivered intact via inhalationit is critical that the method of vaporization does not change thechemical or fundamental molecular structure of the medicant orexcipient. Therefore, there is still a need for improving the routes ofadministration of drugs. In particular, there is still a need forimproving inhalers that can meter exact dosages without destroying theactive ingredient.

SUMMARY

The invention of the present application discloses a method andformulation that can generate a vapor state of a medicant or activeingredient metered at precise dosages without destroying or damaging themedicant or active ingredient, or the excipient solution. In particular,a formulation has been devised in which the solution can be vaporized ata low, focused temperature that ensures vaporization of the excipientand not of the active ingredient; allowing for the inhalation of aspecific, accurate serving or dose of the active ingredient via an inertexcipient. Specifically, an excipient with a low vaporizationtemperature may be combined with an active ingredient that may have ahigher vaporization temperature. In such a combination, the vaporizingexcipient effectively acts as a carrier for the active ingredient. Whenthe combination is heated to a temperature sufficient to vaporize theexcipient, the excipient vapor carries molecules of the activeingredient along with it. Thus, the active ingredient is effectively“vaporized” at a temperature that is usually considerably lower thanneeded to vaporize the active ingredient alone.

In one embodiment, a method for medicant delivery is providedcomprising: providing a medicant solution suitable for vaporization in acompact handheld device; providing the compact handheld device;vaporizing the medicant at a low temperature upon activation by a usersuch that an effective serving of the medicant is provided to the user.

In another embodiment, a medicant solution is provided for use in avaporization delivery mechanism, the solution comprising: water;alcohol; an inert non-reactive compound; and an active ingredient. Insome embodiments, the water and alcohol are optional. In someembodiments, the medicant solution may include glycerin (vegetable orotherwise) and/or flavoring. In some embodiments, the medicant solutionmay include polysorbates (polysorbate 20, 40, 60, 80, or others) and/orpropylene glycol. The medicant solution is formulated such that it canbe vaporized at a low temperature in a sufficient quantity to provide aneffective serving of the active ingredient to a user.

The method and solution is designed to be used with a delivery devicesuch as that described in U.S. patent application Ser. Nos. 13/453,939;13/044,355; and 61/470,460 which applications are incorporated in theirentirety here by this reference.

Accordingly, the method and formulation can be used to vaporize avariety of medicants, preferably, but not necessarily, medicants oractive ingredients directed primarily toward neuro-activity. Forexample, these medicants or active ingredients include, but are notlimited to, caffeine; alkaloids, such as yohimbine and codeine;hormones, such as melatonin and serotonin-classified; antihistamines,such as diphenhydramine; opioids, such as morphine and oxycodone;nootropics, such as piracetam; and amino acids, such asgamma-Aminobutyric acid (GABA), and tobacco constituents.

These medicants or active ingredients can be further classified by theirconsumer/patient use on a PRN (as needed) basis. These classesinclude 1) sleep aids—such as melatonin and gamma-Aminobutyric acid(GABA); 2) motion sickness antidote—such as diphenhydramine; 3)stimulants, such as energy and alertness aids—such as nicotine andcaffeine; 4) analgesics—such as morphine, codeine and oxycodone; and, 5)sexual aids—such as yohimbine, icariin, and type-5 phosphodiesterase(PDE-5) inhibitors.

Other features and advantages of the present invention will becomeapparent from the following detailed description. It should beunderstood, however, that the detailed description and the specificexamples, while indicating the preferred embodiments of the presentinvention, are given by way of illustration only, since various changesand modifications within the spirit and scope of the present inventionwill become apparent to those skilled in the art from this detaileddescription.

DETAILED DESCRIPTION OF THE INVENTION

The detailed description set forth below is intended as a description ofpresently-preferred embodiments of the invention and is not intended torepresent the only forms in which the present invention may beconstructed or utilized. The description sets forth the functions andthe sequence of steps for constructing and operating the invention. Itis to be understood, however, that the same or equivalent functions andsequences may be accomplished by different embodiments that are alsointended to be encompassed within the spirit and scope of the invention.

In order to fully understand the manner in which the above-reciteddetails and other advantages and objects according to the invention areobtained, a more detailed description of the invention will be renderedby reference to specific embodiments thereof.

In one embodiment, a medicant solution is provided comprising anexcipient and an active ingredient or medicant (medicant and activeingredient are used interchangeably), in which the excipient can bevaporized at low temperatures relative to temperatures required bytypical vaporizers. In another embodiment, a medicant delivery method isprovided comprising providing a medicant solution that can be vaporizedat low temperatures, and providing a device for vaporization of themedicant solution such that a user can absorb the vaporized solution viaactivation of the vaporization device to deliver an effective serving ofmedicant to a user.

While an effective serving, effective dose, or therapeutically effectiveamount of a medicant may vary depending upon the particular physiologyof the user, for example, the user's weight or body make-up, as usedherein, the phrases effective serving, effective dose, andtherapeutically effective amount (used interchangeably) means an amountsufficient such that the user experiences the intended positive effectsexperienced when the medicant is delivered through other known methods.In one aspect of this embodiment the effective serving can be deliveredin as little as one activation of the delivery device by the user, andin other aspects the effective serving may be delivered through multipleactivations of the delivery device by the user over 1, 2, 3, 4, 5, 6, 7,8, 9, 10 or more minutes of use in a manner similar to the useassociated with using a portable, handheld aerosol breath freshener.

Alternatively, the effective serving can be delivered over a specifiednumber of activations of the delivery device by the user. Further, thenumber of activations can occur over a specified time period. Forexample, delivery of an effective serving can be provided with 1, 2, 3,4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20activations. For example, the effective dose may be delivered in 1-20activations, 5-15 activations, 12-20 activations, 12-18 activations orabout 15 activations, any of which can occur in a 1, 2, 3, 4, 5, 6, 7,8, 9, 10, or 20 minute period. Some embodiments will be formulatedand/or configured such that the effective dose is delivered as quicklyas possible, and other embodiments can be formulated and/or configuredsuch that the effective dose is delivered in about the same time andmanner as if one were using a portable, handheld aerosol breathfreshener.

In various embodiments, a single serving may be delivered in less than50 activations, about 1-50 activations, about 1-20 activations, about5-15 activations or about 8-10 activations. The single serving mayinclude greater than about 0.5 mg, from about 0.5 mg to about 100 mg,from about 0.5 mg to about 50 mg, from about 0.5 mg to about 20 mg, fromabout 0.5 to about 10 mg, from about 5 mg to about 10 mg, or about 5 mg.

The formulation of the medicant solution comprises an active ingredientand an excipient capable of vaporizing at low temperatures. When themedicant solution is heated, the excipient vaporizes at a relatively lowtemperature, carrying the active ingredient with it. Even though theactive ingredient may have a higher vaporization temperature, theexcipient vapor transports molecules of the active ingredient,delivering the active ingredient to the user at a low temperature.

The active ingredient may be approximately 0.5% or more of the medicantsolution with the remainder of the medicant solution comprising theexcipient. An acceptable range of active ingredient in the medicantsolution ranges from about 0.5% to about 99% or about 0.5% to about 50%of the medicant solution. A medicant solution comprising about 0.5% toabout 20% of the active ingredient is also acceptable. Preferably, themedicant solution comprises between about 0.5% to about 15% of theactive ingredient. More preferably, the medicant solution comprisesabout 5% to about 10% active ingredient. Most preferably, the medicantsolution comprises about 5% active ingredient. The remainder of themedicant solution may be comprised of the excipient.

The excipient may comprise one or more of an inert non-reactivecompound, e.g., propylene glycol, polysorbate, and/or glycerin, suchthat the medicant solution can be vaporized at low temperatures foractivation by a user. In some embodiments, the excipient may furthercomprise water and/or alcohol. In some embodiments, water is present ata concentration of about 0.01% to about 30% of the excipient.Preferably, water is present at about 0.01% to about 20% of theexcipient. More preferably, water is present at about 2% to about 18% ofthe excipient. More preferably, water is present at about 5% to about15%. Most preferably, water is present at about 10% of the excipient.

In some embodiments, alcohol is present at a concentration of about0.01% to about 30% of the excipient. Preferably, alcohol is present atabout 0.01% to about 20% of the excipient. More preferably, alcohol ispresent at about 2% to about 18%. More preferably, alcohol is present atabout 5% to about 15%. Most preferably, alcohol is present at about 10%of the excipient.

In some embodiments, propylene glycol, polysorbate, and/or glycerin canbe used alone or in any combination thereof as the excipient.

In some embodiments, the excipient may comprise propylene glycol.Propylene glycol may be present at about 1% to about 30% of theexcipient. In some embodiments, propylene glycol is present at about 5%to about 20%. In some embodiments, propylene glycol is present at about5% to about 15% or about 10% to about 15%. In some embodiments,propylene glycol may be present at concentrations of at least 70% of theexcipient. In some embodiments, propylene glycol may be present atconcentrations of at least 85% of the excipient. In some embodiments,propylene glycol can make up the entire excipient to which the activeingredient may be added. Therefore, propylene glycol can make up atleast about 1% of the excipient, at least about 5% of the excipient, atleast about 10% of the excipient, at least about 15% of the excipient,at least about 20% of the excipient, at least about 30% of theexcipient, or more.

In another aspect of the invention, the excipient may comprise glycerin,such as vegetable glycerin. In some embodiments, glycerin may be presentat about 1% to about 30% of the excipient. In some embodiments, glycerinmay be present at about 5% to about 20% of the excipient. In someembodiments, glycerin may be present at about 5% to about 10% or about10% to about 15% of the excipient. In some embodiments, glycerin may bepresent at concentrations of at least about 70% of the excipient. Insome embodiments, glycerin may be present at concentrations of at least85% of the excipient. Therefore, glycerin can make up at least about 1%of the excipient, at least about 5% of the excipient, at least about 10%of the excipient, at least about 15% of the excipient, at least about20% of the excipient, at least about 30% of the excipient, or more. Insome embodiments, glycerin can make up the entire composition of theexcipient to which the active ingredient may be added. Without beinglimited by theory, it is believed that the addition of glycerin providesa more robust vapor upon vaporization of the product.

In some embodiments, the excipient may comprise a compound from thepolysorbate class or family, such as polysorbate 20 (polyoxyethylenesorbitan monolaurate), polysorbate 40 (polyoxyethylene (20) sorbitanmonopalmitate), polysorbate 60 (polyoxyethylene sorbitan monostearate),and polysorbate 80 (polyoxyethylene sorbitan monooleate).

The polysorbate compound used in the excipient may be polysorbate 20,polysorbate 40, polysorbate 60, polysorbate 80, or a polysorbatecomposition comprising any combination thereof. The type of polysorbateused or the combination of polysorbates used depends on the intendedeffect desired as the different polysorbates offer different attributesdue to the different molecule sizes of the different polysorbate. Forexample, the polysorbate molecules increase in size from polysorbate 20to polysorbate 80. There is a sliding scale effect of vapor amount ordensity and lung penetration with increasing size of polysorbatemolecules. Using smaller size polysorbate molecules creates less of avapor, but permits deeper lung penetration. This may be desirable whenthe user is out in public where he would not want to create a largeplume of “smoke” (i.e. vapors). This effect can be achieved, forexample, if the excipient comprises about 70% to about 100% polysorbate20 or polysorbate 40.

Conversely, if a dense vapor is desired, then the larger polysorbatemolecules, such as polysorbate 80 or polysorbate 60, can predominate thepolysorbate composition used in the excipient. For example, thepolysorbate composition may comprise about 70% to about 100% polysorbate80 or polysorbate 60. Therefore, characteristics, features, andattributes of the medicant solution and the resultant vapor can becontrolled by using a polysorbate composition with a specificcombination of polysorbate 20, polysorbate 40, polysorbate 60, and/orpolysorbate 80.

Polysorbate, meaning any polysorbate from the polysorbate family, andany combination thereof, may be present at about 1% to about 30% of theexcipient. In some embodiments, polysorbate is present at about 5% toabout 20% of the excipient. In some embodiments, polysorbate is presentat about 5% to about 15% or about 10% to about 15% of the excipient. Insome embodiments, polysorbate may be present at concentrations of atleast 70% of the excipient. In some embodiments, polysorbate may bepresent at concentrations of at least 85% of the excipient. In someembodiments, polysorbate can make up the entire excipient to which theactive ingredient may be added. Therefore, polysorbate can make up atleast about 1% of the excipient, at least about 5% of the excipient, atleast about 10% of the excipient, at least about 15% of the excipient,at least about 20% of the excipient, at least about 30% of theexcipient, or more. Without being bound by theory, it is believed thatpolysorbate provides a more robust vapor upon vaporization, reduces theheat of vaporization, and produces smaller vapor molecules, therebyachieving deeper lung penetration upon inhalation.

In another aspect of this invention, the medicant solution furthercomprises flavoring.

The medicant solution is formulated such that an effective serving ofthe active ingredient can be delivered to a user in a specified timeperiod when the medicant solution is vaporized and inhaled by the user.In one aspect of this embodiment the effective serving can be deliveredover a specified time period when the solution is vaporized without theaddition of heat.

Depending on the form of the active ingredient the medicant solution maybe prepared by combining a tincture of an active ingredient with theexcipient. In some embodiments, the medicant solution may be prepared bycontacting the active ingredient with the excipient. In other words, themedicant solution is prepared by extracting the active ingredient fromits source (for example, herbs, plants, roots, etc.) with the excipient.The final concentration of the active ingredient may be controlled bythe time, temperature, and pressure at which the source is in contactwith the excipient.

Active ingredients may be extracted from their respective sources by avariety of methods. For example, to promote leaching of the activeingredient from its source, various methods may be employed to contactthe source with the excipient, including maximizing the surface area ofthe source. In one embodiment, the source is formed in the shape of amesh screen through which the excipient is passed. While the excipientis passed through the source, the active ingredient is extracted fromthe source into the excipient. In other configurations, the source isformed to provide the maximum surface area for contact with theexcipient yet still allow flow of the excipient through the source andinto a vaporization device. Examples of other configurations for use inmaximizing the surface area of the source for contact with the excipientinclude spirally winding the source, converting the source into pellets,converting the source into powder, or encapsulating the source in aporous, filter-like material, which will allow the excipient to flowthrough the source-encapsulate allowing the active ingredient to leachinto the excipient from its source. Leaching, or extraction in general,may also be promoted through modifying the temperature of the excipientor the pressure under which the excipient is contacted with the source.

In some embodiments the excipient and the medicant source are contactedimmediately prior to vaporization. In other embodiments the excipientand medicant source can be contacted over an extended period of timeprior to vaporization. For example, the medicant source can be providedimmersed in the excipient such that the excipient has been in contactwith the medicant source for an extended period of time prior tovaporization. In such examples, the leaching or extraction of the activeingredient can be promoted by varying the conditions or other parametersduring contact of the excipient with the medicant source. The medicantsource can be removed from the formed medicant solution prior toproviding the medicant solution to the end consumer for inclusion in adevice for vaporization, or immediately prior to vaporization bydraining the medicant solution from the medicant source.

The medicant solution is then vaporized by activation of a vaporizationor delivery device by the user. Examples of vaporizers (particularly,hand-held low temperature vaporizer) or delivery devices that may beused to vaporize the medicant solution are disclosed in U.S. patentapplication Ser. Nos. 10/587,707; 10/547,244; 13/453,939; 13/044,355;61/470,460, incorporated herein by reference. Other devices may be used,which include atomizers or other vaporizers known in the art orcombinations thereof. Vaporization or atomization can be performed withor without the addition of heat to the solution. For example, thesolution to be vaporized can first be atomized providing for ease ofvaporization without the addition of heat. In one aspect a lowtemperature vaporizer is provided.

The temperatures referred to in this application refer to thetemperature of the heating element of a vaporizer that contacts themedicant for vaporization or the temperatures at which the medicants arevaporized. Low temperature means a temperature for vaporizing a medicantthat is lower than traditional temperatures used for vaporizingmedicants. For example, traditional temperatures rely on heatingelements that reach 300 degrees Celsius (C.) or higher for vaporizingliquids. Therefore, low temperatures mean temperatures less than orequal to approximately 280 degrees C., and preferably less than or equalto approximately 250 degrees C. In some embodiments, low temperaturesare from approximately 90 degrees C. to approximately 280 degrees C. Insome embodiments, low temperatures may be from approximately 180 degreesC. to approximately 250 degrees C. In some embodiments, low temperaturesmay be from approximately 180 degrees C. to approximately 225 degrees C.In some embodiments, low temperatures may be from approximately 180degrees C. to approximately 200 degrees C.

As indicated above, low temperatures also refer to the heat ofvaporization of the medicant solution, where the heat of vaporizationmeans the temperature at which the medicant solution vaporizes from aliquid state to a gaseous state. Therefore, the heat of vaporization forthe medicant solution (e.g., the temperature the heating element of thevaporizer must reach to vaporize the medicant) may be from approximately90 degrees C. to approximately 280 degrees C. In some embodiments, theheat of vaporization for the medicant solution is from approximately 180degrees C. to approximately 250 degrees C. In some embodiments, the heatof vaporization for the medicant solution is from approximately 180degrees C. to approximately 225 degrees C. In some embodiments, the heatof vaporization may be from approximately 180 degrees C. toapproximately 200 degrees C.

In some embodiments, an excipient with a lower heat of vaporization maybe used, including but not limited to excipients comprising polysorbate.In such embodiments, low temperatures for vaporization may be fromapproximately 90 degrees C. to approximately 200 degrees C., fromapproximately 90 degrees C. to approximately 180 degrees C., fromapproximately 90 degrees C. to approximately 160 degrees C., fromapproximately 90 degrees C. to approximately 150 degrees C., fromapproximately 90 degrees C. to approximately 140 degrees C., or fromapproximately 90 degrees C. to approximately 120 degrees C., and anytemperatures therebetween.

In embodiments in which propylene glycol is used as the excipient, lowtemperatures for vaporization may be from approximately 90 degrees C. toapproximately 250 degrees C., from approximately 110 degrees C. toapproximately 225 degrees C., from approximately 150 degrees C. toapproximately 210 degrees C., or from approximately 170 degrees C. toapproximately 200 degrees C., and any temperatures therebetween.

In embodiments in which vegetable glycerin is used as the excipient, lowtemperatures for vaporization may be from approximately 90 degrees C. toapproximately 280 degrees C., from approximately, 110 degrees C. toapproximately 280 degrees C., from approximately 150 degrees C. toapproximately 280 degrees C., from approximately 200 degrees C. toapproximately 280 degrees C., from approximately 225 degrees C. toapproximately 280 degrees C., or from approximately 250 degrees C. toapproximately 280 degrees C., and any temperatures therebetween.

Therefore, depending on the composition of the excipient, lowtemperatures can range from as low as 90 degrees C. up to 280 degrees C.and any temperature therebetween.

In another embodiment, a device for implementing the medicant deliverymethods set forth herein is provided comprising a shell, a mouthpiece,an air inlet provided on the external wall of the shell, a cell, anelectronic circuit board, a normal pressure cavity, a sensor, anatomizer, a solution reservoir, a medicant reservoir, a solution streampassage, a negative pressure cavity provided in the sensor, anatomization cavity arranged in the atomizer, and an aerosol passage,wherein the solution reservoir is in contact with the medicant reservoirand the atomizer, and the air inlet, normal pressure cavity, atomizer,aerosol passage, gas vent and mouthpiece are interconnected.

In another embodiment, a device for implementing the medicant deliverymethods set forth herein is provided comprising a shell, a mouthpiece,an air inlet provided on the external wall of the shell, a cell, anelectronic circuit board, a normal pressure cavity, a sensor, anatomizer, a solution reservoir, a solution stream passage, a negativepressure cavity provided in the sensor, an atomization cavity arrangedin the atomizer, and an aerosol passage, wherein the solution reservoiris in contact with the atomizer, and the air inlet, normal pressurecavity, atomizer, aerosol passage, gas vent and mouthpiece areinterconnected. The solution reservoir may be configured to retain amedicant solution and medicant, or medicant solution that has previousbeen contacted with medicant.

In some embodiments the device is provided in the configuration of acigar or cigarette. In other embodiments the device is provided in otherconfigurations such that the device can be readily distinguished from acigar or cigarette.

In some embodiments, the delivery device is a hand-held, personalportable device that is disposable. Moreover, in some embodiments themethod of vaporization uses low temperatures to vaporize the medicantsolution.

In another embodiment a disposable cartridge is provided comprising amedicant solution or medicant (or active ingredient) and an excipient asset forth herein. The cartridge can include one or more servings ofmedicant as set forth herein. In one aspect of this embodiment thecartridge can include between about 5-50 servings, between about 5-25servings, between about 10-25 servings, between about 10-50 servings,between about 10-20 servings of medicant.

Ingestion via vapor inhalation provides effects within 30 to 90 seconds.The quick, efficient method of inhalation ingestion provides for lowerdoses and significantly minimizes the risk of over dosing and itsattendant complications, as the effects are almost immediately felt.This reduces the tendency to take more medication before the effectshave set on as in the case of orally ingested drugs that are absorbedthrough the digestive tract. Accordingly, the invention of the presentapplication provides users with an easy-to-use, convenient medicantproduct.

EXAMPLES

Examples of medicants or active ingredients that can be used with thepresent invention include, but are not limited to, nicotine and othertobacco constituents; caffeine; alkaloids, such as yohimbine andcodeine; hormones, such as melatonin and serotonin-classified;antihistamines, such as diphenhydramine; opioids, such as morphine andoxycodone; nootropics, such as piracetam; amino acids, such asgamma-Aminibutyric acid (GABA); plants and herbs, such as green tea,hoodia, yohimbine, and epimedium; and compounds involved in signaltransduction pathways, such as type-5 phosphodiesterase (PDE-5)inhibitors.

These and any other active ingredients can be used as stimulants,alertness aids, cognitive enhancers, sleep aids, motion sicknessantidotes, analgesics, sexual aids, and other conditions known to betreatable with these active ingredients.

Tobacco Constituents

Smokers of traditional tobacco products, for example, cigarettes, cigarsand pipes, are finding that their use of these products has beensignificantly and seriously curtailed by smoking regulations passed andenacted due to concerns about the public health dangers of second handsmoke, and potentially harmful chemicals found in the smoke, includingtar and carbon monoxide.

In addition to traditional tobacco alternatives to those that must beignited, cigarettes, cigars ad pipes, like snuff, snus, chewing tobacco,tobacco tablets, tobacco lozenges and tobacco strips, smokers recentlyhave also be utilizing electronic nicotine delivery devices ore-cigarettes. These products vaporize nicotine, allowing a smoker toinhale a nicotine-infused vapor in a manner similar to smoking.

However, nicotine is just one constituent of tobacco that providessatisfaction to smokers. There are a number of others—actual tobaccoflavor, aroma, and monoamine oxidase inhibitors. As used herein, desiredtobacco constituent means one or more of tobacco flavor, aroma,monoamine oxidase inhibitors, and nicotine.

Monoamine oxidase inhibitors (“MAOIs”) are naturally found in tobaccoand naturally occur in tobacco smoke. These naturally occurring tobaccoconstituents are also used in anti-depressants and are widelyacknowledged to be mood elevators.

While there have been inventions that teach as to using actual leaftobacco in certain combinations that then vaporize the constituentswithout ignition, they combine tobacco in certain and specific formswith solutions that require heating to a temperature range of at least200 degrees C.

As used in this application, a “first solution” is an excipient solutionprior to its contact with an active, such as tobacco to form a “tobaccosolution.” In some circumstances, a first solution may have had previoustobacco contact, but will eventually have subsequent tobacco contact toform a “tobacco solution.”

Vaporization at 200 degrees C. represents a relatively low temperaturecompared to other current e-cigarettes, but there are compelling reasonsfor seeking first solutions (i.e. excipient solutions) that vaporize atmuch lower temperatures. These reasons include a) minimizing power needsto reach temperatures of less than 200 degrees C., allowing for saferand more efficiently powered devices; and, b) using first solutionscomprised of smaller molecules, allowing for deeper lung penetrationupon inhalation and more efficacious absorption of the tobaccoconstituents, which, in turn, will allow for more efficient use oftobacco and its constituents—which would be beneficial and desirableshould governmental authorities determine that e-cigarettes need to belimited with respect to the volume of tobacco or the density of nicotineand/or other constituents provided in a commercially-availableproduct/device. Those potential limitations notwithstanding, lowtemperature vaporization of tobacco formulations using first solutionswith smaller molecules than currently being utilized and vaporizationpoints well under 200 degrees C. will prove to be more effective andefficacious with respect to providing a safer alternative to the publichealth risks associated with traditional tobacco products intended to beignited and smoked.

Accordingly, there is a need in the art for a more effective and safertobacco delivery mechanism and method of use that provides forvaporization at temperatures well under 200 degrees C. and, ideally, atno more than 100 degrees C.

In one embodiment of the present invention a method for tobacco deliveryis provided comprising: providing tobacco; providing a first solution;contacting the tobacco with the first solution to form a tobaccosolution comprising tobacco constituents; and vaporizing the tobaccosolution. In other aspects of this embodiment the step of vaporizing thetobacco solution comprises using a piezoelectric element to atomize thetobacco solution without the addition of heat and the tobaccoconstituents comprise nicotine and at least one monoamine oxidaseinhibitor derived from tobacco. In another aspect of this embodiment,the step of vaporizing the tobacco solution comprises using a lowtemperature vaporizer to vaporize the tobacco solution and the tobaccoconstituents comprise nicotine and at least one monoamine oxidaseinhibitor derived from tobacco. These steps could be used independentlyor combined, such as atomizing the solution and then vaporizing it.

In another embodiment of the present invention a tobacco solution foruse in a vaporization delivery mechanism is provided comprising: water;alcohol; propylene glycol; and tobacco constituents. In one aspect ofthis embodiment the tobacco constituents comprise nicotine and at leastone monoamine oxidase inhibitor derived from tobacco.

In another embodiment of the present invention a device for tobaccodelivery is provided comprising: a first solution reservoir comprising afirst solution; tobacco; a vaporization mechanism, wherein the solutionis contacted with the tobacco to form a tobacco solution comprisingtobacco constituents, and wherein the tobacco solution is then providedto the vaporization mechanism. In one aspect of this embodiment thevaporization mechanism comprises a piezoelectric element to atomize thetobacco solution without the addition of heat. In another aspect of thisembodiment the vaporization mechanism comprises a low temperatureelement to vaporize the tobacco solution at a low temperature. Inanother aspect of this embodiment the tobacco constituents comprisenicotine and at least one monoamine oxidase inhibitor derived fromtobacco.

In another embodiment of the present invention, a tobacco solution isprovided prepared by a process comprising the steps of: providingtobacco; providing a first solution comprising water, alcohol, andpropylene glycol; contacting the first solution with the tobacco to forma tobacco solution comprising tobacco constituents. In one aspect ofthis embodiment, the step of contacting the first solution with thetobacco to form a tobacco solution comprises immersing the tobacco inthe first solution for a time sufficient to extract the tobaccoconstituents from the tobacco. In another aspect of this embodiment, thetobacco constituents comprise nicotine and at least one monoamineoxidase inhibitor derived from tobacco. In another aspect of thisembodiment, the first solution further comprises glycerin.

In another embodiment of the present invention, the alcohol,polypropylene glycol, and/or glycerin from the tobacco solution arereplaced with one or more of the polysorbate family ofcompounds—polysorbate 20 (polyoxyethylene sorbitan monolaurate),polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate),polysorbate 60 (polyoxyethylene sorbitan monostearate) and polysorbate80 (polyoxyethylene sorbitan monooleate.) All members of the polysorbatefamily have much smaller molecules than those of other well-knownexcipients in e-cigarettes—propylene glycol, vegetable glycerin, etc.Additionally, all members of the family have vaporization temperatures(boiling points) at 100 degrees C. and flash points at 137 degrees C.Current technology in e-cigarette devices, using their method ofvaporization and a power source that is essentially uncontrolled (i.e.lithium batteries that are controlled by external forces, rather than bybattery capacity and state of charge), do not have the ability to limitthe heat of the vaporizing element to 100 degrees C. and will always runthe risk of heating the solution well past the flash point of 137degrees C., thereby essentially breaking the molecule and causingfundamental molecular changes in the excipient and in the solution.Additionally, the vapor molecule of the polysorbate is much smaller thanthat of propylene glycol and vegetable glycerin and, in theory, shouldbe able to achieve deeper lung penetration than those excipients,requiring a smaller amount of active ingredients—tobacco constituents—toachieve efficacious results.

For example, one activation of a device used with the current method candeliver the equivalent desired tobacco constituents from one puff from atypical tobacco cigarette. In other embodiments, one activation may beconfigured to deliver 1, 2, 3, 4, 5, 10, 20, 30, 40, 50, 60, 70, 80, or90 percent of the desired tobacco constituents from one puff of atobacco cigarette. Such embodiments are described as delivering apercentage of the effect serving of one or more desired tobaccoconstituents. In one aspect of this embodiment, the method delivers aspecified percentage, e.g., 1, 2, 3, 4, 5, 10, 20, 30, 40, 50, 60, 70,80, or 90 percent, of tobacco flavor, aroma, monoamine oxidaseinhibitors, nicotine, or any other target constituent or combinationthereof, in a single serving.

The solution may be any solution sufficient to allow the constituents ofthe tobacco to leach or be extracted into the solution upon contact withthe fibrous tobacco for a specified time period to form a tobaccosolution. Examples of suitable solutions include one or more of water,alcohol, and an inert non-reactive compound, for example propyleneglycol. The solution can comprise about 0.01% to about 20% water, about2% to about 18% water, about 5% to about 15% water, or about 10% water;about 0.01% to about 20% alcohol, about 2% to about 18% alcohol, about 5to about 15% alcohol, or about 10% alcohol, with the balance beingpropylene glycol. In another aspect of this embodiment, the solutionfurther comprises glycerin, including from about 1% to about 30%, about5 to about 20%, about 5% to about 10%, or about 10% to about 15%glycerin.

Without being limited by theory, it is believed that the addition ofglycerin provides a more robust vapor upon vaporization of the productand promotes the extraction or leaching of nicotine and other desirablecomponents from the tobacco.

In tobacco solutions using polysorbates, the effective serving orportion of tobacco constituents may be approximately 0.5% or more of thetobacco solution. An acceptable range of tobacco constituents in thetobacco solution ranges from about 0.5% to about 99% or about 0.5% toabout 50% of the tobacco solution. A tobacco solution comprising about0.5% to about 20% tobacco constituents is also acceptable. Preferably,the tobacco solution comprises between about 0.5% to about 15% tobaccoconstituents. More preferably, the tobacco solution comprises about 5%to about 10% tobacco constituents. Most preferably, the tobacco solutioncomprises about 5% tobacco constituents.

The polysorbates make up the remainder of the tobacco solution.Therefore, the tobacco solution can comprise up to 99.5% of polysorbate.

Some embodiments provided herein produce a vapor containing the keyconstituents of tobacco that smokers find most appealing, comforting andsatisfying without many of the harmful components created throughburning the tobacco.

In another embodiment, a tobacco solution is provided for use in themethods and devices disclosed herein. The tobacco solution comprisesactual tobacco constituents, including nicotine, flavor, aroma andMAOIs. The tobacco solution may be formed by contacting a solution asset forth herein with tobacco as set forth herein to form a tobaccosolution. The concentration of the actual tobacco constituents of thetobacco solution can be varied by varying the method for making thetobacco solution. For example, one can vary the contact time between thesolution and the tobacco, the temperature at which the contact occurs,or the pressure at which the contact occurs. The tobacco solution may beprovided with or without tobacco in contact with the tobacco solution.

Stimulants and Cognitive Enhancers

Caffeine is an alkaloid, a bitter substance found in coffee, tea, softdrinks, chocolate, kola nuts, and certain medicines. It has many effectson the body's metabolism, including stimulating the central nervoussystem. This makes the consumer more alert and provides a boost ofenergy. Accordingly, caffeine may be used as the medicant in theinvention of the present application.

Sleep Aids

Diphenhydramine is a first generation antihistamine mainly used to treatallergies and available in over the counter, non-prescriptivemedications like Benadryl. Like most other first generationantihistamines, the drug also has a powerful hypnotic effect, and forthis reason is often used as a non-prescription sleep aid.Diphenhydramine is thought to block the re-uptake of histamineneurotransmitters, thereby causing histamine to build up in the spacescalled synapses that are present between nerve cells. This leads tosedative effects. Diphenhydramine works both centrally within the brainas well as in peripheral nerve cells in other parts of the body. Itpossesses other effects and can counter nausea due to motion sickness.

Among the traditional methods for ingesting diphenhydramine as a sleepaid is by mouth in various and readily available digestible compounds.It would be more effective, quicker acting and less likely to causegastro-intestinal distress or discomfort if diphenhydramine were morequickly transported to the brain through the cardio-pulmonary system byingesting and inhaling a vaporized product containing Diphenhydramine. Afast-acting diphenhydramine may be particularly useful for relievingmotion sickness in progress, or as a sleep aid taken at or afterbedtime. Accordingly, Diphenhydramine may be used as the medicant in theinvention of the present application.

Doxylamine is also a first generation antihistamine often used as asleep aid. Doxylamine is a member of the ethanolamine class ofantihistamines and has significant anti-allergy properties. As a sleepaid it works by depressing the central nervous system to producedrowsiness. Doxylamine succinate is used in certain formulations of theover-the-counter products Unisom and Nyquil, and could be implemented inthe invention according to the methods described above forDiphenhydramine and for similar uses. Accordingly, doxylamine could alsobe used as the medicant in the invention of the present application.

Melatonin is a naturally occurring compound, a hormone, found inanimals, plants, and microbes. In animals, melatonin is made by thepineal gland, a small gland in the brain. Very small amounts of it arefound in foods such as meats, grains, fruits, and vegetables. It can bepurchased as a dietary supplement.

Circulating levels of melatonin vary in a daily cycle, therebyregulating the circadian rhythms of several biological functions,including controlling the sleep wake cycles. Many biological effects ofmelatonin are produced through activation of melatonin receptors, whileothers are due to its role as a pervasive and powerful antioxidant, witha particular role in the protection of nuclear and mitochondrial DNA.

Today, melatonin is used for a variety of purposes, but most often usedfor human sleep enhancement by regulating the sleep-wake cycle bycausing drowsiness and lowering body temperature and affecting thecentral nervous system.

Among the traditional methods or ingesting melatonin is by mouth invarious and readily available digestible compounds. When used as a sleepaid, melatonin is typically taken 30-60 minutes prior to bedtime, toallow the melatonin time to dissolve in the stomach and absorb into theblood stream to take effect. It would be more effective, quicker actingand less likely to cause gastro-intestinal distress or discomfort ifmelatonin were more quickly transported to the brain through thecardio-pulmonary system by ingesting and inhaling a vaporized productcontaining melatonin. A quick-acting melatonin would be particularlyhelpful as a sleep aid when taken at or after bedtime. Accordingly,melatonin may be used as the medicant in the present application.

Valerian (Valeriana officinalis, Caprifoliaceae) is a perennialflowering plant, which has long been used as a medicinal herb, includingas a sleep aid. The root of the plant and its extracts are most oftenused as a sleep aid. Typical preparations sold as dietary supplementsinclude capsules with dried root, and an extract of the essential oil.Research is not conclusive, but it is thought to interact with the GABAreceptor. Compounds known to be in valerian that may contribute to itsmethod of action include Alkaloids: actinidine, chatinine, shyanthine,valerianine, and valerine, Gamma-aminobutyric acid (GABA), Isovalericacid, Iridoids, including valepotriates: isovaltrate and valtrate,Sesquiterpenes (contained in the volatile oil): valerenic acid,hydroxyvalerenic acid and acetoxyvalerenic acid, and Flavanones:hesperidin, 6-methylapigenin, and linarin. Accordingly, valerian couldalso be used as the medicant in the invention of the presentapplication.

Analgesics

Analgesics may also be used as a medicant in the present application.GABA is traditionally known as an inhibitory neurotransmitter involvedin regulating neuronal communications through GABA receptors. GABA isnaturally occurring in the human body. Supplementing a diet with GABAmay have various benefits, including but not limited to analgesicbenefits. Accordingly, GABA may be used as the medicant in the presentapplication.

Opioids are recognized as the benchmark of the class of analgesics usedto relieve or to manage severe or agonizing pain and suffering. Althoughopioids are substances that act in a similar way as opiates, for thepurposes of this application, the term opioid and opioids will includeand encompass opiates. Therefore, opiates are of the opioid class ofdrugs and are analgesic alkaloid compounds found naturally in the opiumpoppy plant. Opiates can be classified as follows: natural opiates,semi-synthetic opiates and synthetic opiates. Examples of naturalopiates are morphine, codeine, and thebaine. Examples of semisyntheticopiates include heroin, hydrocodone, hydromorphone, oxycodone, andoxymorphone. Synthetic opiates include fentanyl, buprenorphine, andmethadone. All opioids, including the opiates, are considered drugs ofhigh abuse potential and are listed under the Controlled Substances Act.

In addition to being controlled substances and having high abusepotential, opioids, when administered under the care of a physician andsubject to all relevant pharmaceutical and regulatory mandates,generally are delivered orally or by intravenous injection, traveling,in first case, through the gastro-intestinal tract, then through theblood stream, and to the central nervous system. These forms of deliveryhave significant side-effects, which include, but are not limited to,gastro-intestinal distress, itching, nausea, vomiting, drowsiness, drymouth, miosis, orthostatic hypotension, urinary retention, depressionand constipation.

One of the earliest forms of opiate ingestion was through inhalation—inthe earliest form, through igniting a natural opiate and inhaling thesmoke produced. Inhalation of the opiate avoids the gastro-intestinaltract—and, as a result, avoids many of the most common side-effects,transports through the cardio-pulmonary tract, and delivers itsanalgesic effects much quicker and more efficiently. However, smokingand the inhaling is inexact and impossible to dose or prescribe in anefficacious manner.

Certain vaporizing technologies (such as those described in U.S. Pat.No. 8,903,228, U.S. patent application Ser. No. 14/004,150, and U.S.application Ser. No. 13/453,939, which applications are incorporatedhere by this reference in their entirety) now allow for accurate dosingand for controlled temperature of the heating element being used tovaporize. These technologies also could offer safeguards as toauthentication and verification of the user before dispensing, and aredesigned so as to be impossible to contaminate, adulterate ormisappropriate; or for the user to administer at times other thanprescribed and, or more often, than in specific time periods other thanthose prescribed.

These vaporizing technologies combine the opiate with an excipient. Forexample, the excipient may comprise a polysorbate, inclusive ofpolysorbates 20, 40, 60 and 80, propylene glycol (“PG”), or vegetableglycerin (“VG”). These excipients vaporize at relatively lowtemperatures. For example, on the low end, excipients comprisingpolysorbates may vaporize at temperatures of about 90 degrees C. or 100degrees C. up to about 200 degrees C. On the high end, excipientscomprising PG and/or VG may vaporize at temperatures up to approximately250 degrees C. or approximately 280 degrees C.

In some embodiments, the temperature for vaporizing any of the medicantscan be as high as 385 degrees C. Therefore, the temperature forvaporizing medicants can range from approximately 90 degrees C. toapproximately 385 degrees C. For example, the opioid-containingmedicants can be vaporized at temperatures from approximately 330degrees C. to approximately 385 degrees C. Preferably, the temperaturemay be from approximately 340 degrees C. to approximately 380 degrees C.More preferably, the temperature may be from approximately 370 degreesC. to approximately 380 degrees C.

Given the side-effects and risks associated with the most common methodsof opiate delivery and the additional risks of abuse and subsequentrecovery; and given the systemic societal cost of regulating, policingand rehabilitating those who have come to abuse and those who workoutside the regulations to encourage such abuse, there is a need in theart for formulations that can be vaporized by devices designed todeliver more safely, more effectively and more securely, ensuringaccurate dosages, verified and prescribed users and properself-administration by the user—at no more than prescribed daily dosagesand at the prescribed times.

The following detailed description of certain opioids is not meant to belimiting; any opioid could be used as a medicant in the presentapplication. Morphine is highly regarded as an analgesic to relievesevere or agonizing pain and suffering. Morphine is the most abundantalkaloid found in opium. Like other opioids, e.g. morphine (OxyContin,Percocet, Percodan), hydromorphone (Dilaudid, Palladone), anddiacetylmorphine (heroin), morphine acts directly on the central nervoussystem (CNS) to relieve pain. Among the traditional methods or ingestingmorphine is by intravenous injection, traveling through the blood streamto the central nervous system. Morphine has a high potential foraddiction; tolerance and psychological dependence develop rapidly. Itwould be more effective, quicker acting and less likely to causegastro-intestinal distress or side effects such as itching, nausea,vomiting, drowsiness, dry mouth, miosis, orthostatic hypotension,urinary retention, depression and constipation if morphine was morequickly transported to the brain through the cardio-pulmonary system byingesting and inhaling a vaporized product containing morphine.Accordingly, morphine, as well as any of its derivatives or analogs, maybe used as a medicant in the invention of the present application.

Codeine is an opiate analgesic drug that is used to relieve moderate tosevere pain. Like morphine it is an alkaloid found in opium. Like otheropiates, codeine acts directly on the central nervous system (CNS) torelieve pain. Codeine has a high potential for addiction; tolerance andpsychological dependence develop rapidly. It would be more effective,quicker acting and less likely to cause side effects if codeine was morequickly transported to the brain through the cardio-pulmonary system byingesting and inhaling a vaporized product containing codeine.Accordingly, codeine may be used as a medicant in the invention of thepresent application.

Oxycodone is an opioid analgesic medication synthesized frompoppy-derived thebaine. It was developed in 1916 in Germany, as one ofseveral new semi-synthetic opioids in an attempt to improve on theexisting opioids, morphine and codeine. Oxycodone oral medications aregenerally prescribed for the relief of moderate to severe pain.Currently it is formulated as single ingredient products or compoundedproducts. Some common examples of compounding are oxycodone withacetaminophen/paracetamol or NSAIDs such as ibuprofen. The formulationsare available as generics but are also made under various brand names.

Among the traditional methods or ingesting oxycodone is by mouth invarious and readily available digestible compounds. It would be moreeffective, quicker acting and less likely to cause gastro-intestinaldistress or side effects such as itching, nausea, vomiting, drowsiness,dry mouth, miosis, orthostatic hypotension, urinary retention,depression and constipation if oxycodone was more quickly transported tothe brain through the cardio-pulmonary system by ingesting and inhalinga vaporized product containing oxycodone. Accordingly, oxycodone may bea medicant used in the invention of the present application.

When used for pain, inhaling an active ingredient, which is rapidlyeffective, may minimize a user from taking additional doses whilewaiting for pain relief. Such rapid effects may lead to lower dosing andless tendency to overmedicate, which may lead to less chance ofaddiction, and less complications from overmedication.

Appetite Suppressants

Appetite suppressants exist naturally in certain plants. For example,green tea and the hoodia plant are believed to contain activeingredients that can suppress appetite. Numerous other plants andchemical compounds are also believed to have appetite suppressantproperties. However, it may not be practical to consume enough of theseplant substances or extracts, such as green tea or hoodia, through thedigestive system to feel the full effects. In addition, a rapidly-actingappetite suppressant may be beneficial in helping a user counteractsudden urges to eat. Accordingly, green tea, hoodia, and other appetitesuppressant substances may be a medicant used in the invention of thepresent application, including with the extraction or leaching methodsdescribed herein.

Sexual Aids

Compounds for use as a sexual aid to help or enhance the performance ofsexual function can also be used with the present invention, such asyohimbine, icariin, and type-5 phosphodiesterase (PDE-5) inhibitors.

Yohimbe is the principal alkaloid of the bark of a West Indian evergreentree. It is used as a supplement to arouse sexual excitement, forerectile dysfunction (ED), sexual problems caused by medications fordepression called selective-serotonin reuptake inhibitors (SSRIs), andgeneral sexual problems in both men and women. It is also used forathletic performance, weight loss, exhaustion, chest pain, high bloodpressure, low blood pressure that occurs when standing up, diabeticnerve pain, and for depression along with certain other medications.Yohimbe contains a chemical called yohimbine which can increase bloodflow and nerve impulses to the penis or vagina. It also helps counteractthe sexual side effects of certain medications used for depression.Yohimbe may be a medicant used in the invention of the presentapplication.

Epimedium, also known as barrenwort, bishop's hat, fairy wings, hornygoat weed, rowdy lamb herb, randy beef grass or yin yang huo, is a genusof flowering plants in the family Berberidaceae. Epimedium contains theactive compound icariin, which like sildenafil, the active ingredient inViagra, inhibits the activity of phosphodiesterase type 5 (PDE-5).However, the bioavailability via oral administration of this medicant isvery low and the herb (and its active ingredient) would be much moreeffective when administered via vapor through the cardio-pulmonarysystem. Thus, there is a need for low temperature vaporization of theherb/medicant for ingestion via inhalation. As such, epimedium and theactive compound icariin may be a medicant used in the invention of thepresent application.

PDE-5 inhibitors have been used to treat erectile dysfunction due totheir ability to increase blood flow in the corpus cavernosum of thepenis. In general, sexual stimulation results in nitric oxide release inthe corpus cavernosum. Nitric oxide increases cyclic guanosinemonophosphate (cGMP) levels, which results in smooth muscle relaxationin the arteries of the corpus cavernosum. Relaxation of the smoothmuscle allows for increase in the blood flow in the corpus cavernosumresulting in an erection.

PDE-5 exists naturally in the walls of the smooth muscles of the corpuscavernosum. PDE-5, however, breaks down the cGMP that causes smoothmuscle relaxation. Therefore, PDE-5 can restrict blood flow in thecorpus cavernosum. PDE-5 inhibitors block the action of PDE-5, therebyincreasing blood flow to the corpus cavernosum. A PDE-5 inhibitor takenorally as a pill can take an hour or more for its effect to take place.As such, some spontaneity is lost in using current forms of PDE-5inhibitors.

As such, providing PDE-5 inhibitors via an inhalable vapor may restoresome of the spontaneity in sexual activity by increasing the efficacyand speed with which PDE-5 inhibitors can take effect due to a morerapid uptake of the PDE-5 inhibitors through the lungs and into thecardiovascular system. In addition, grabbing a vaporization device andtaking a quick puff is more convenient, faster, and easier than havingto take pills out of a container, grabbing a glass of water, and thenwaiting for the effects to take place.

Examples of PDE-5 inhibitors include, but are not limited to, avanafil,sildenafil, tadalafil vardenafil, avanafil, lodenafil, mirodenafil,udenafil, zaprinast, icariin, benzamidenafil, and dasantafil.

In addition to use for erectile dysfunction, PDE-5 inhibitors may alsohave other uses. For example, since PDE-5 is also present in the smoothmuscle of the lungs, PDE-5 inhibitors have been explored and used forthe treatment of pulmonary hypertension, including but not limited topulmonary arterial hypertension. PDE-5 inhibitors have also been used toalleviate vasospasm and to treat ischemia and ulcers in fingers and toesfor people with secondary Raynaud's phenomenon. The uses of the PDE-5inhibitors disclosed herein may not be limited to treating erectiledysfunction.

The categorization of the compounds described above is not meant to belimiting, but rather illustrative of the potential uses of the presentinvention. It is understood that some compounds disclosed herein can beused to treat other conditions within the spirit and scope of thepresent invention.

In addition, numerous other medicants can be used with the presentinvention. As such, the foregoing description of the preferredembodiment of the invention has been presented for the purposes ofillustration and description. It is not intended to be exhaustive or tolimit the invention to the precise form disclosed. Many modificationsand variations are possible in light of the above teaching. It isintended that the scope of the invention not be limited by this detaileddescription, but by the claims and the equivalents to the claimsappended hereto.

What is claimed is:
 1. A method for delivering medicants throughinhalation, comprising: a. acquiring a medicant solution suitable forvaporization, the medicant solution, comprising: i. an excipientcomprising propylene glycol present at approximately 1 percent toapproximately 30 percent of the excipient, vegetable glycerin present atapproximately 1 percent to approximately 30 percent of the excipient,water present at approximately 0.01 percent to approximately 30 percentof the excipient, and alcohol present at approximately 0.01 percent toapproximately 30 percent of the excipient, and ii. phosphodiesterasetype 5 inhibitor; and b. vaporizing the medicant solution at atemperature ranging from approximately 90 degrees C. to approximately385 degrees C. such that an effective serving of the medicant solutionis provided to a user for inhalation, wherein the step of vaporizing themedicant solution comprises using a vaporizer.
 2. A method fordelivering medicants through inhalation, comprising: a. acquiring amedicant solution suitable for vaporization, the medicant solution,comprising: i. an excipient comprising an inert non-reactive compound,and ii. a phosphodiesterase type 5 inhibitor; and b. vaporizing themedicant solution at a temperature ranging from approximately 90 degreesC. to approximately 385 degrees C. within 2 minutes of activation suchthat an effective serving of the phosphodiesterase type 5 inhibitor isprovided to the user for inhalation.
 3. The method of claim 2, whereinthe step of vaporizing the medicant solution comprises using a lowtemperature vaporizer.
 4. The method of claim 3, wherein the inertnon-reactive compound is polysorbate.
 5. The method of claim 4, whereinthe polysorbate is present at a concentration of at least about 1percent of the excipient.
 6. The method of claim 4, wherein thepolysorbate is present at a concentration of at least about 10 percentof the excipient.
 7. The method of claim 4, wherein the polysorbate ispresent at a concentration of at least about 30 percent of theexcipient.
 8. The method of claim 4, wherein the polysorbate is presentat a concentration of at least about 70 percent of the excipient.
 9. Themethod of claim 4, wherein the polysorbate is present at a concentrationof at least about 85 percent of the excipient.
 10. The method of claim4, wherein the polysorbate comprises about 100 percent of the excipient.11. The method of claim 4, wherein the temperature is about 90 degreesC. to about 120 degrees C.
 12. The method of claim 3, wherein theexcipient comprises any one or more polysorbate compound selected fromthe group consisting of polysorbate 20, polysorbate 40, polysorbate 60,and polysorbate
 80. 13. The method of claim 3, wherein the inertnon-reactive compound is propylene glycol.
 14. The method of claim 13,wherein the propylene glycol is present at a concentration of at leastabout 1 percent of the excipient.
 15. The method of claim 13, whereinthe propylene glycol is present at a concentration of at least about 10percent of the excipient.
 16. The method of claim 13, wherein thepropylene glycol is present at a concentration of at least about 30percent of the excipient.
 17. The method of claim 13, wherein thepropylene glycol is present at a concentration of at least about 70percent of the excipient.
 18. The method of claim 13, wherein thepropylene glycol is present at a concentration of at least about 85percent of the excipient.
 19. The method of claim 13, wherein thepropylene glycol comprises 100 percent of the excipient.
 20. The methodof claim 13, wherein the temperature is from approximately 170 degreesC. to approximately 200 degrees C.
 21. The method of claim 13, whereinthe excipient further comprises glycerin.
 22. The method of claim 3wherein the inert non-reactive compound is glycerin.
 23. The method ofclaim 22, wherein the glycerin is present at a concentration of at leastabout 1 percent of the excipient.
 24. The method of claim 22, whereinthe glycerin is present at a concentration of at least about 10 percentof the excipient.
 25. The method of claim 22, wherein the glycerin ispresent at a concentration of at least about 30 percent of theexcipient.
 26. The method of claim 22, wherein the glycerin is presentat a concentration of at least about 70 percent of the excipient. 27.The method of claim 22, wherein the glycerin is present at aconcentration of at least about 85 percent of the excipient.
 28. Themethod of claim 22, wherein the glycerin comprises about 100 percent ofthe excipient.
 29. The method of claim 22, wherein the temperature isfrom approximately 250 degrees C. to approximately 280 degrees C. 30.The method of claim 3, wherein the phosphodiesterase type 5 inhibitor isselected from the group consisting of avanafil, sildenafil, tadalafilvardenafil, avanafil, lodenafil, mirodenafil, udenafil, zaprinast,benzamidenafil, and dasantafil.